The objects of the invention are pressure sensitive adhesive compositions that have improved resistance to intestinal fluid and ostomy devices utilizing these adhesives for attachment to the body, collection of intestinal fluid or collection of effluent from a stoma.
The most common commercial ostomy devices have two basic requirements for acceptable performance, attachment of the device to the peristomal area and containment of effluent from the stoma. These requirements are met by two discreet components of the device, referred to as the base plate, body wafer or wafer (for attachment) and the pouch or bag (for collection). The wafer and pouch work together to protect the peristomal skin and provide a secure means for discrete collection and disposal of effluent.
The wafer and pouch components may be coupled together by a variety of means including thermal, ultrasonic, radio frequency, or other kinds of plastic welds, hot melt or reactive or curable glues, pressure sensitive adhesives, and various mechanical means. When these components are permanently joined together, for example when the coupling mechanism is a plastic weld or glue joint, then the product is considered a one piece appliance. Two piece appliances are devices in which the pouch and wafer components can be separated while preserving the usefulness of one or both components. Two piece devices can be made using coupling mechanisms based on pressure sensitive adhesives or from mechanical couplings of various designs. An example of a mechanical coupling is described by British Patent specification GB 1 571 657.
Both one piece and two piece ostomy devices have advantages and disadvantages. The one piece design is typically very flexible, conforms well to the body, and is less noticeable under clothing compared with two piece products which tend to be more rigid and higher profile. In a two piece design, the wafer can be separated, from a pouch and reconnected with the same or different pouch. The two piece design offers several advantages, the primary one being that the pouch can be removed and changed without having to change the wafer, which requires additional work and stresses the skin. Other advantages of the two piece design are that the stoma and peristomal area can be observed and, if needed, treated without removing the wafer or destroying the pouch. One piece products generally do not provide these advantages.
The coupling mechanism is of significant importance in determining the usefulness of an ostomy device since it strongly influences the flexibility, convenience, and versatility of the device. It also impacts the most important need for the wearer, containment of effluent. Like the other components of the device, the coupling must contain all effluent from the stoma, which may be emitted in solid, liquid or gaseous forms. Permanent couplings like thermal welds between the wafer and pouch are simple and effective mechanisms for reliable containment of stoma output but suffer the drawbacks of the one piece design. For this reason ostomy devices having two piece mechanical couplings are sometimes preferred. However, mechanical couplings are typically more rigid and have a higher profile than the couplings of one piece designs, and can be uncomfortable and less discrete for the wearer. They also require sufficient manual dexterity and visual acuity to properly assemble or disassemble. However, a properly designed mechanical coupling like the one described in GB 1 571 657 yields a pouch to wafer connection that provides excellent security and containment characteristics.
Coupling mechanisms based on bonding together an ostomy pouch and wafer using pressure sensitive adhesives can combine the advantages of both one piece and two piece designs if they enable repeatable and secure attachment of the pouch and wafer, yield a low profile device, and provide reliable containment of effluent. A pressure sensitive adhesive based ostomy device coupling is defined herein as comprising a pressure sensitive adhesive, in adhesive contact with the surface of at least one other ostomy device component.
There are numerous prior art disclosures that describe the use of adhesives in ostomy device couplings. UK Patent 1,274,382 discloses a post surgical drainage device for receiving discharge from a surgical wound or stoma, and an attachment means for securing that device to the patient's body. The attachment means is comprised of two laminar parts assembled in face to face relationship. The first part of the attachment means comprises an adhesive for securing the attachment means to the body. The second part of the attachment means is a flexible plastic sheet that secures to the pouch by means of an adhesive.
U.S. Pat. No. 4,701,169 discloses an ostomy appliance comprising a body-attachable pad and a means whereby a plurality of ostomy bags can be adhesively attached to the pad in sequence by exposing a fresh layer of adhesive each time it is desired to attach a clean bag.
U.S. Pat. No. 5,160,330 discloses a water closet disposable pouch having an adhesive disc secured to an inside wall of the bag for use in connecting the bag to a flange worn on the body.
U.S. Pat. No. 5,496,296 discloses an adhesively coupled ostomy pouch and faceplate device wherein the faceplate contains an adhesive that may be squeezed out from a compartment in the faceplate to form a peristomal gasket.
U.S. Pat. No. 5,709,673 discloses a flushable ostomy pouch of either a one piece or two piece design wherein the two piece design includes an adhesive coupling to join together the wafer and pouch.
U.S. Pat. No. 5,722,965 discloses an adhesively coupled ostomy device comprising a repositionable foam tape that inhibits the formation of wrinkles in the coupling mechanism.
Patent Application WO99/26565 discloses an ostomy system comprising a pouch that is adhesively coupled to a mounting wafer. The mounting wafer has a landing zone film of releaseable plastic. The landing zone has one portion that is immovable with respect to the body surface and another part that is deflectable away from the body surface to which it is attached.
Patent application WO00/30576 discloses an ostomy appliance comprising a body side member and a receiving bag each including a flange said to be designed for removable adhesive connection of the appliance components wherein the collecting bag flange incorporates perforations to reduce the risk of leakage.
Patent application WO01/85074 discloses a carrier device comprising a base plate with flange for adhesive connection with an ostomy collecting bag wherein the outer portion of the flange is free to move relative to the base plate.
The preceding patents and patent applications all disclose ostomy device couplings in which both the body attaching and effluent collecting components have essentially only planar regions whereby they are attached together using an adhesive. There are additional prior art disclosures that describe ostomy device couplings made from flexible components that are substantially non-planar and which function by being assembled in more than two dimensions. U.S. Pat. No. 4,808,173 discloses a coupling ring assembly for an ostomy device in which one of the rings has a radially-facing annular channel for receiving a latching flange of another ring. A deformable, viscoelastic polymeric material lines the channel where the two coupling rings are attached. It is stated that additional security may be obtained if the liner also has adhesive properties.
U.S. Pat. No. 4,826,495 discloses a water closet flushable ostomy bag and a retainer plate to which it may be coupled by means of a pressure sensitive adhesive. The retainer plate includes a hollow bead projecting into the pouch which is said to provide a passage way for flatus to pass out of the pouch.
U.S. Pat. No. 5,429,626 discloses an ostomy appliance having a mounting member for attachment to the skin, the mounting member comprising a rigid mounting plate on its distal side and an axially extending curb for alignment of the pouch. The pouch is provided with an annular band of adhesive to removably adhere it to the mounting plate.
U.S. Pat. No. 5,346,482 discloses a two piece ostomy appliance comprising a flushable pouch that may be attached to an ostomy faceplate with an adhesive. The faceplate component has an axially extending protective collar that inserts into the pouch to shield water-soluble layers of the pouch from the fluids that enter it.
Patent Application WO97/35534 discloses a coupling device for mounting an ostomy bag to the body comprising annular sealing elements and annular bonding regions on both the pouch and wafer. At least one of the bonding regions is provided with a layer of repositionable adhesive. The sealing elements are said to cooperate to form a water tight seal while the bonding regions form a releaseable bond.
U.S. Pat. No. 5,800,415 discloses an ostomy collecting system comprised of a collecting bag and a base plate, each of which has an annular flange for adhesive coupling. Also disclosed is an axially extending collar that acts as a guide surface to prevent improper mounting of the bag and which forms a passage for the stoma, providing protection of the coupling adhesive from stomal effluent.